Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan

Completed · Not applicable

Conditions studied: Aortic Valve Stenosis

In brief

The purpose of this study is to evaluate contrast media volume, safety and 30-day outcome of patients after a computed tomography (CT) scan. The results of this study will help to determine the minimum volume of contrast material that can be used to ensure patient safety while not compromising diagnostic image quality in high-risk patients.

Key facts

Study ID: NCT01843426
Run by: Medical University of South Carolina
People needed: 40
Starts: 2013-02-01
Expected to finish: 2017-09-25
Last updated by the study team: 2018-08-02

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject must be 18-90 years of age.
Subject must have been referred for a clinically indicated CT prior to TAVR.
Subject must provide written informed consent prior to any study-related procedures being performed.
Subject must be willing to comply with all clinical study procedures.

You may not qualify if…

Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
By testing (serum or urine βHCG) within 24 hours before contrast agent administration, or
By surgical sterilization, or
Post menopausal, with minimum one (1) year history without menses.
Subject has an acute psychiatric disorder or is cognitively impaired.
Subject is using or is dependent on substances of abuse.
Subject is unwilling to comply with the requirements of the protocol.
Subject has previously entered this study.
Subject has an allergy against iodinated contrast agents.
Subject is in acute unstable condition.

Where it is running

Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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